Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: September 17, 2019

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Lenalidomide - Generic Drug Details

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What are the generic sources for lenalidomide and what is the scope of lenalidomide patent protection?

Lenalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are twenty-one patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lenalidomide has five hundred and six patent family members in forty-six countries.

There are fourteen drug master file entries for lenalidomide. One supplier is listed for this compound.

Pharmacology for lenalidomide
Synonyms for lenalidomide
(3S)-3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione
1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline
191732-72-6
2, 3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-
2,6-Piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-
2,6-piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-, (3S)-
3-(4-amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-2,6-dioxopiperidine
3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-2,6-piperidinedione
3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione
3-(4-Amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
3-(4-Amino-1-oxo-2-isoindolinyl)piperidine-2,6-dione
3-(4-amino-1-oxo-2,3-dihydro-1H-isoindol-2-yl)piperidine-2,6-dione
3-(4-amino-1-oxo-isoindolin-2-yl)piperidine-2,6-dione
3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione
3-(4-amino-1,3-dihydro-1-oxo-2h-isoindol-2-yl)-2,6-piperidinedione
3-(7-Amino-3-oxo-1H-isoindol-2-yl)-piperidine-2,6-dione
3-(7-amino-3-oxo-1H-isoindol-2-yl)piperidine-2,6-dione
346670-73-3
4-amino-2-(6-hydroxy-2-oxo-2,3,4,5-tetrahydropyridin-3-yl)-2,3-dihydro-1H-isoindol-1-one
443912-14-9
732L726
AB0017965
AB01273975_03
AB01273975-01
AB01273975-02
ABP001089
AC-914
AC1L50II
ACN-034469
AK-47482
AKOS005146276
AKOS005174869
ALBB-015321
AM20050439
AN-1103
API0003142
AX8136128
BC220870
BCP01390
BCP9000847
BCPP000186
BDBM65454
BR-47482
CAS-191732-72-6
CC 5013
CC 5013; Revimid
CC-5013
CDC 501
CDC-501
CDC-5013
CHEBI:63791
CHEMBL848
CS-0125
CTK8E1915
D04687
DB00480
DSSTox_CID_26664
DSSTox_GSID_46664
DSSTox_RID_81806
DTXSID8046664
ENMD 0997
ENMD-0997
FT-0659651
FT-0670758
GOTYRUGSSMKFNF-UHFFFAOYSA-N
GTPL7331
HMS3654G07
HSDB 8220
HY-A0003
I06-0831
IMid-1
IMID-5013
IMiD3
KB-53181
KS-00000GHH
KS-1207
Lenalidomide (CC-5013)
Lenalidomide (USAN/INN)
Lenalidomide [USAN:INN:BAN]
Lenalidomide [USAN]
LS-184040
MCULE-9771679074
MFCD07772307 (97%)
MLS003899194
MolPort-003-848-370
NCGC00167491-01
NCGC00167491-02
NCGC00167491-03
NCGC00167491-04
NSC-747972
NSC747972
PubChem19113
Q-101410
Revimid
Revlimid
Revlimid (Celgene)
Revlimid (lenalidomide)
Revlimid (TN)
Revlimid (TN) (Celgene)
Revlimid, Lenalidomide, CC-5013
RTR-008901
S-4172
s1029
SCHEMBL1980410
SCHEMBL32978
SMR002529986
SR-01000883999
SR-01000883999-1
STK639603
SW218084-2
SY047646
T5245
Tox21_112492
Tox21_112492_1
TR-008901
Z1741976709
ZX-AN014029

US Patents and Regulatory Information for lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Expired US Patents for lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Supplementary Protection Certificates for lenalidomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0925294 SPC033/2007 Ireland ➤ Sign Up SPC033/2007: 20080507, EXPIRES: 20220613
2105135 00140 Estonia ➤ Sign Up
2105135 122015000013 Germany ➤ Sign Up PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 300717 Netherlands ➤ Sign Up PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 212 50002-2015 Slovakia ➤ Sign Up PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2105135 CA 2015 00006 Denmark ➤ Sign Up PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.